Atomix LLC
FDA issued a warning letter to Atomix LLC (Sheridan, WY) in December 2025 after reviewing the company's website, Instagram, and Facebook accounts and finding that it was selling unapproved new drugs marketed as selective androgen receptor modulators (SARMs), specifically MK-2866 (Ostarine/Enobosarm) and RAD-140 (Testolone). Despite 'research use only' disclaimers, FDA determined the products were intended for human use based on marketing claims about muscle growth, bone health, and treatment of conditions like sarcopenia, cachexia, and osteoporosis. The products lack FDA-approved applications under section 505 of the FD&C Act, making their interstate sale a violation of sections 301(d) and 505(a). FDA warned that failure to correct violations may result in seizure and injunction.
Flagged claims (6)
MK-2866, also known as Ostarine or Enobosarm, is a nonsteroidal selective androgen receptor modulator (SARM). It has been widely studied for its anabolic effects on muscle and bone while minimizing androgenic activity in other tissues.
Ostarine, also known as MK-2866, is a selective androgen receptor modulator (SARM) that has been shown to stimulate muscle tissue proliferation and differentiation. It enhances muscle cell proliferation and protein synthesis, which can be beneficial for conditions like sarcopenia and cachexia.
RAD-140 promotes lean muscle growth, enhances strength, and supports bone density, without significant prostate or liver toxicity being observed in traditional anabolic agents. It has also shown potential neuroprotective effects in models of neurodegeneration[.]
MK-2866 enhances lean muscle mass, improves strength, and supports skeletal integrity[.]
Ostarine (MK-2866) offers potential benefits in muscle growth and bone health, making it a candidate for treating conditions like muscle wasting and osteoporosis.
RAD-140, also known as Testolone, is a nonsteroidal selective androgen receptor modulator (SARM) designed to mimic the anabolic effects of testosterone while minimizing androgenic activity in non-muscular tissues.
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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